The FDA recently approved a drug called Intermezzo for use in the middle of the night wakening that is followed by difficulty returning to sleep. The drug is Ambien, but the dosage is much smaller and the indication is new. Here is another example of a drug company coming up with a novel treatment that treats the symptoms but not the cause. It also has potential side effects that can be worrisome such as grogginess the following day, amnesia for activity during the night such as eating, driving, having a phone conversation and sleep walking.
In two clinical trials of only 370 patients, those taking the drug had a shorter time to fall back to sleep compared to placebo. I suspect the overall benefit compared to placebo was statistically significant but not that impressive or there would be much more raving about its benefit. Other side effects include headache, nausea and fatigue.
